Vedanta opens manufacturing facility to produce lead candidate as it heads for PhIII
The microbiome startup Vedanta, while still forging ahead with the Phase III process for its Clostridioides difficile infection candidate, has completed a manufacturing facility to produce the drug.
Vedanta’s new 7,000-square-foot facilities in Cambridge, MA, are designed to manufacture clinical and commercial supplies for its portfolio, including their oral c. difficile candidate VE303.
The facility is an extension of the company’s existing manufacturing capabilities and can produce multiple drug candidates, according to Vedanta. It also has CGMP capabilities to handle everything from clinical development to commercial launch. Manufacturing is expected to kick off in Q4 of this year.
The cost of the facility and employment details were not disclosed to Endpoints News, though Vedanta did confirm in an email that government funds were given to the company. The company is a funded contractor of BARDA and support went to Vedanta’s lead program and select aspects of the facility design and commissioning, Vedanta said.
In October of 2021, positive Phase II results triggered a $23.8 million option from BARDA. The funds have been used to support the candidate in several capacities including manufacturing.
“This facility, combined with the expertise and talent of our team, is designed to manufacture our microbiome product candidates as standardized compositions with consistent quality attributes at a large scale,” Vedanta CEO Bernat Olle said in a statement.
The company’s first production runs at the new facility will supply a planned Phase III study of VE303, but the timeline of that trial has not been disclosed to Endpoints.
Vedanta has been on the charge as of late with its lead candidate. In 2021, it wrapped up a $68 million Series D raise, which included a $25 million equity investment from Pfizer. The company netted a $45.5 million C round in 2019.